Efficacy on Anxiety of the Digital Music Application Versus Equimolar Mixture of Oxygen and Nitrous Oxide in Patients Receiving CT-guided Lumbar Infiltration

Recruiting now · Not applicable

Conditions studied: Low Back Pain, Anxiety

In brief

Since the Covid-19 crisis, patients appear more stressed, with increasing fear of exams and the hospital environment, in particular for CT scan teams, which require injections. Currently, an equimolar mixture of oxygen and nitrous oxide (EMONO) is used to calm patients. However, the patient's prone position complicates its use, with patients sometimes in painful position and the discomfort of gas inhalation (nausea, dizziness, etc.), as well as reduced lung capacity. Greater patient anxiety increases the risk of complications, or even failure, (unexpected movement, stiffness, refusal to complete the procedure, etc.). In this study, music therapy using Music Care® tablets, was tested to replace EMONO. The study authors hypothesize that the use of the Music Care® device will have a comparable efficacy to that of EMONO (non-inferiority) in reducing patient anxiety during CT-guided lumbar infiltration. Furthermore, the study authors hypothesize that this simple, non-invasive method, with no contraindications for the patient, will be better tolerated and appreciated by both the patient and the paramedical team in charge of the treatment.

Key facts

Study ID

NCT06928740

Run by

Centre Hospitalier Universitaire de Nīmes

People needed

128

Starts

2025-10-21

Expected to finish

2029-06-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• Patients with low back pain for whom scan-guided infiltration is indicated, whether at the foraminal level, posterior joints, pudendal, epidural, sacroiliac, or via the sacrococcygeal hiatus.
• Patient with an anxiety score ≥ 35/100 based on the STAI-ETAT questionnaire

You may not qualify if…

• The subject is participating in another drug or category I interventional study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• Indication for epidural injection
• Patient who is deaf or hard of hearing
• Contraindications to EMONO
• Facial or head trauma making it impossible to wear a nasofacial mask or headphones

Where it is running

• CHU de Nimes — Nîmes, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.